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Ascyrus Medical Dissection Stent Hybrid Prosthesis - Aortic arch endovascular stent-graft

Australia TGA ARTG Registered Device · Cryolife Medical (Australia) Company Pty Ltd · Ascyrus Medical GmbH · Class III · Started May 24, 2023

Good Name: Cryolife Medical (Australia) Company Pty Ltd - Ascyrus Medical Dissection Stent Hybrid Prosthesis - Aortic arch endovascular stent-graft

Device classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
May 24, 2023
Effective Date
May 24, 2023
Sponsor
Manufacturer
Country
Germany
Address
Grosse Gallusstrasse 16-18, Frankfurt am Main, 60312
Intended purpose

The AMDS is intended for aortic repair, aortic remodeling and re-expansion of the intimal flap within the ascending aorta, aortic arch, and into the descending aorta for patients with acute DeBakey Type I aortic dissections undergoing open surgical repair within 0-14 days of diagnosis.

About this record

Access comprehensive regulatory information for Ascyrus Medical Dissection Stent Hybrid Prosthesis - Aortic arch endovascular stent-graft in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Cryolife Medical (Australia) Company Pty Ltd, manufactured by Ascyrus Medical GmbH in Germany. The device registration started on May 24, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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